Contents of this document
- Decrease in R&D expenses-¥270 million
- Decrease in rogocekib research and development expenses-¥272 million
- Increase in U.S. CRO costs+¥248 million
- Decrease in drug substance and drug product-related costs-¥521 million
- Decrease in other general and administrative expenses-¥46 million
- Increase in non-operating income and extraordinary gainsUp ¥32 million year on year
- Increase in non-operating expenses and extraordinary losses+¥18 million
- Fundraising through the 12th series of stock acquisition rights to complete the rogocekib expansion cohort, conduct the DDI study, and prepare for the start of the Phase 2 clinical trial
- Preparation for an international joint clinical trial, including Japan, using AMED's "GRiT" program
- Pursuit of domestic and international business partnerships focused on rogocekib
- Improving fixed-cost efficiency and concentrating management resources on rogocekib
- Total clinical trial enrollment129 People
- Enrollment in Japan60 Engagements
- Enrollment in the United States70 Engagements
- Patients in the dose-escalation cohorts of the U.S. Phase 1/2 trial42 cases
- IE cohort enrollment27 cases
- Overall response rate (U.S. trial)11.8 %
- Overall response rate (Japanese Phase 1 trial)42.9 %
| Item | Details |
|---|---|
| Document type | Presentation materials for financial results |
| Fiscal Period Covered | Fiscal year ending August 2026 |
| Operating profit | ¥-1,473 million |
| Ordinary income | -1,452 Million yen (net loss before income taxes) |
| Net income | ¥-1,455 million |
| Selling, general and administrative expenses | 318 Million yen (other general and administrative expenses) |
| Self-assessment against the plan | Research and development and information disclosure progressed broadly as planned, but no business partnership was realized. |
| Breakdown of Factors Affecting the Change | Factors Decrease in R&D expenses / Amount -¥270 million, Factors Decrease in rogocekib research and development expenses / Amount -¥272 million, Factors Increase in U.S. CRO costs / Amount +¥248 million, Factors Decrease in drug substance and drug product-related costs / Amount -¥521 million, Factors Decrease in other general and administrative expenses / Amount -¥46 million, Factors Increase in non-operating income and extraordinary gains / Amount Up ¥32 million year on year, Factors Increase in non-operating expenses and extraordinary losses / Amount +¥18 million |
| Key KPIs | Indicator name Total clinical trial enrollment / Value 129 People / Year on year against the same period last year Not disclosed, Indicator name Enrollment in Japan / Value 60 Engagements / Year on year against the same period last year Not disclosed, Indicator name Enrollment in the United States / Value 70 Engagements / Year on year against the same period last year Not disclosed, Indicator name Patients in the dose-escalation cohorts of the U.S. Phase 1/2 trial / Value 42 cases / Year on year against the same period last year Not disclosed, Indicator name IE cohort enrollment / Value 27 cases / Year on year against the same period last year Not disclosed, Indicator name Overall response rate (U.S. trial) / Value 11.8 % / Year on year against the same period last year Not disclosed, Indicator name Overall response rate (Japanese Phase 1 trial) / Value 42.9 % / Year on year against the same period last year Not disclosed |
| Number of employees | Number of Employees 22 People / Changes during the period and hiring plan Not disclosed |
| New initiatives | Fundraising through the 12th series of stock acquisition rights to complete the rogocekib expansion cohort, conduct the DDI study, and prepare for the start of the Phase 2 clinical trial, Preparation for an international joint clinical trial, including Japan, using AMED's "GRiT" program, Pursuit of domestic and international business partnerships focused on rogocekib, Improving fixed-cost efficiency and concentrating management resources on rogocekib |
Items this document does not state (20)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Research and development expenses decreased because, although U.S. CRO costs increased, manufacturing-related costs during the period were limited as a certain amount of drug substance and drug product for clinical trials had already been secured. General and administrative expenses decreased due to the impact of the pro forma standard taxation associated with the capital reduction, patent-related costs, and fixed-cost reduction measures.